We have extensive experience of installing ISO 9000 Quality Systems, especially for medical device manufacturers (ISO 13485 series), and offer help and advice to manufacturers embarking on such installation for the first time, or where subsequent certification audit has disclosed system deficiencies requiring corrective action.

RSQA is especially strong in the sterile device sector and can advise
on all aspects related to medical device microbiology including sterilization
technologies. Our consultants have a wealth of expertise in the practical
application of Ethylene Oxide, Moist Heat, Dry Heat and Gamma and
Electron Beam Irradiation, and the appropriate European / ISO Standards.
We can also advise on meeting regulatory requirements where novel
sterilization methods are to be used.

The interface between medicinal products and medical devices.

As an adjunct to our consultancy services we also conduct training courses from time to time. See our Training page for more information.

Further information

For further information please email us or call us on +44 (0) 207 936 9412.